A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.
This single arm study will assess the safety and efficacy of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response or intolerance to one or more anti-TNF agents. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Drug: rituximab [MabThera/Rituxan]
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Study to Evaluate the Safety, and Effect on Treatment Response, of MabThera in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One or More Anti-TNF Agents.|
- Change From Baseline in Disease Activity Score Based on 28-Joint Count (DAS28) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]DAS28 was calculated from the number of swollen joints, or swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (measured in millimeters per hour [mm/hr]), and Patient Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A clinically significant improvement in DAS28 was a change of at least 1.2 units.
- Percentage of Participants Achieving American College of Rheumatology (ACR) Response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]ACR20/50/70 response defined as greater than or equal to (≥)20 percent (%), 50%, or 70% improvement, respectively, in TJC and SJC, and ≥20%/50%/70% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain, Patient Global Assessment of Disease Activity, Physician Global Assessment of Disease Activity, self-assessed disability based on the Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-Reactive Protein (CRP).
- Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Category [ Time Frame: Week 24 ] [ Designated as safety issue: No ]Percentage of participants with a EULAR response at Week 24 based on a scale of good response, moderate response, or no response. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders have a change from baseline greater than (>)1.2 with DAS28 less than or equal to (≤)3.2; moderate responders have a change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders have a change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.
- Change From Baseline in HAQ-DI Score [ Time Frame: Week 24 ] [ Designated as safety issue: No ]The Stanford HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Responses in each component set are scored from 0 (without any difficulty) to 3 (unable to do). The highest score recorded for any question in a category determines the score for the category, unless aids, devices, or help from another person is required. The HAQ-DI score is calculated as the sum of the category scores divided by the number of categories scored, giving a possible range of scores from 0 to 3. Scores of 0 to 1 are generally considered to represent "mild to moderate difficulty", 1 to 2 as "moderate to severe disability", and 2 to 3 as "severe to very severe disability".
|Study Start Date:||July 2007|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Drug: rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15Drug: Methotrexate
10-25mg/week po or parenteral
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504777
|Changhua, Taiwan, 500|
|Kaohsiung, Taiwan, 807|
|Kaohsiung, Taiwan, 813|
|Kaohsiung, Taiwan, 00833|
|Taichung, Taiwan, 402|
|Taichung, Taiwan, 404|
|Taichung, Taiwan, 407|
|Taipei, Taiwan, 00112|
|Taoyuan, Taiwan, 333|
|Tapei, Taiwan, 114|
|Study Director:||Clinical Trials||Hoffmann-La Roche|